[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Notices]
[Pages 83133-83134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26201]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-102 and CMS-105]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, Health and Human 
Services (HHS).

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of information 
(including each proposed extension or reinstatement of an existing 
collection of information) and to allow 60 days for public comment on 
the proposed action. Interested persons are invited to send comments 
regarding our burden estimates or any other aspect of this collection 
of information, including the necessity and utility of the proposed 
information collection for the proper performance of the agency's 
functions, the accuracy of the estimated burden, ways to enhance the 
quality, utility, and clarity of the information to be collected, and 
the use of automated collection techniques or other forms of 
information technology to minimize the information collection burden.

DATES: Comments must be received by January 29, 2024.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number: __, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, please access 
the CMS PRA website by copying and pasting the following web address 
into your web browser: https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-102 and CMS-105--CLIA Budget Workload Reports and Supporting 
Regulations in 42 CFR 493.1-.2001

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: CLIA Budget Workload Reports and Supporting Regulations in 
42 CFR 493.1-.2001; Use: The Clinical Laboratory Improvement Amendments 
of 1988 (CLIA), Public Law 100-578 were enacted on October 31, 1988. 
Provisions of this law mandated by Congress require entities (with few 
exceptions) that test human specimens be subject to Federal regulation 
and have in effect a certificate issued by the Department of Health and 
Human Services. CLIA mandates that fees must be paid by each laboratory 
to obtain or renew a certificate and for the cost of

[[Page 83134]]

compliance determination if applicable. The certificate issuance fees 
will be set by CMS at levels sufficient to recover the full costs of 
administering the operational provisions of CLIA, including approval 
and monitoring of proficiency testing programs and accrediting bodies 
and implementing Federal requirements. Fees will also be collected by 
CMS to cover the costs of inspecting non-accredited laboratories and 
validating accrediting laboratories based on the lab's volume and scope 
of testing. Currently, CMS contracts with 50 State agencies to conduct 
surveys of all participating health care facilities. As part of their 
contract, CMS reimburses the State agencies for the reasonable cost of 
conducting surveys. This information collection gathers the information 
necessary to reimburse State agencies for a reasonable cost. Form 
Number: CMS-102 and CMS-105 (OMB control number: 0938-0599); Frequency: 
Yearly/Quarterly; Affected Public: State, Local or Tribal Governments; 
Number of Respondents: 50; Total Annual Responses: 50; Total Annual 
Hours: 34. (For policy questions regarding this collection contact Eric 
Powell at 312-886-0791).

    Dated: November 22, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2023-26201 Filed 11-27-23; 8:45 am]
BILLING CODE 4120-01-P